Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced the publication of a prospective, randomized controlled trial showing clinical utility of the Prospera test. The study concluded that practicing nephrologists who used the Prospera test detected more cases of rejection and made better clinical decisions than physicians in the control group. The study evaluated kidney transplant patients in typical scenarios seen by nephrologists in routine practice. The study was published in International Urology and Nephrology,1 and is available to read here.
"The Prospera test can be a vital tool in early detection and the treatment decision-making process of our patients," said Jessica Coleman, MD, Nephrologist at Beaufort Memorial Hospital. "When we evaluate patient scenarios with the Prospera test, we gain insights to help increase the chances of a successful transplant and improved outcomes."
The Prospera test's previously published clinical validation showed excellent performance in the detection of active kidney transplant rejection.2 This latest study measured the clinical practice of 154 nephrologists with and without dd-cfDNA testing. To determine whether the use of the Prospera test demonstrated overall clinical utility, 924 simulations were completed. The study, conducted by QURE Healthcare and researchers from a top academic institution, showed that those using the Prospera test to evaluate post-transplant patients were more likely to reach an early, accurate diagnosis and appropriately change their treatment compared to those using creatinine and other routine biomarkers alone.
Highlights of the study concluded:
-- Use of the Prospera test led to a 300 percent increase in probability of confirming rejection via biopsy in both routine and in ambiguous clinical scenarios.
-- Nephrologists using the Prospera test to identify rejection more than doubled the appropriate referrals to transplant centers and/or biopsies.
-- Prospera test results yielded a 137 percent improvement in treatment decisions that preserved kidney function.
"The results of this study provide valuable insights into the Prospera test's capabilities and utility in the nephrology practice," said Paul Billings, MD, PhD, Natera's Chief Medical Officer and a co-author on the study. "Results clearly show that the use of the Prospera test demonstrated clinical utility and improved care of the emulated patients through changes in diagnosis, workup, and management after kidney transplant."
About the Prospera dd-cfDNA Organ Transplant Test
The Prospera test leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. The Prospera test has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The Prospera test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
ContactsInvestor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., firstname.lastname@example.org
-- Peabody J, Billings P, Valdenor C, et al. Randomized clinical trial of a novel donor-derived cfDNA test to detect rejection in CPV-simulated renal transplant patients. Int Urol Nephrol. 2020;52(8):1593-1601.
-- Sigdel TK, Archila FA, Constantin T, et al. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2019;8(1):19.
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SOURCE Natera, Inc.